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FDA Proposes New Division, Office of Pharmaceutical Quality (OPQ)
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FDA Proposes New Division, Office of Pharmaceutical Quality (OPQ)

The Food and Drug Administration (FDA) is ramping up preparations for a proposed a new division, the Office of Pharmaceutical Quality (OPQ), within its Center for Drug Evaluation and Research (CDER). The new office would exercise authority over the pharmaceutical manufacturing process throughout a product’s entire life cycle, taking over and consolidating some responsibilities from the existing Office of Manufacturing and Product Quality and the Office of Pharmaceutical Science. The FDA says OPQ is intended to become a “global benchmark for regulation of pharmaceutical quality,” that will oversee the full spectrum of medicines, including brand-name, generic, and over-the-counter drugs.

The FDA’s perceived need to establish the office underscores both the importance of pharmaceutical manufacturing processes and the concern over the recent surge in quality-control problems throughout the industry. Drug shortages have emerged as a growing problem in recent years, for example, and an FDA industry survey revealed that the single largest factor causing the shortages was a manufacturing quality issue. The agency lists “Safety and Quality” as one of its five strategic priorities for the next four years.

At a panel during the Biotechnology Industry Organization’s annual convention on June 24, Russell Wesdyk, scientific coordinator for the FDA’s Office of Pharmaceutical Science, stressed that the FDA doesn’t intend to replace existing regulations but rather is looking to sharpen its focus under the existing regulatory umbrella. Read more on OPQ.

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